Details for New Drug Application (NDA): 214850
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NDA 214850 describes ERIBULIN MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Chia Tai Tianqing, Dr Reddys, Gland, Glenmark Pharms, Jiangxi Kvvit Pharm, Long Grove Pharms, Natco, Sandoz, and Xgen Pharms, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the ERIBULIN MESYLATE profile page.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
Summary for 214850
| Tradename: | ERIBULIN MESYLATE |
| Applicant: | Long Grove Pharms |
| Ingredient: | eribulin mesylate |
| Patents: | 0 |
Pharmacology for NDA: 214850
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 214850
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 214850 | ANDA | BluePoint Laboratories | 68001-656 | 68001-656-41 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-656-41) / 2 mL in 1 VIAL, SINGLE-DOSE |
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 214850 | ANDA | Northstar Rx LLC | 72603-368 | 72603-368-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-368-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/2ML (0.5MG/ML) | ||||
| Approval Date: | Jul 18, 2024 | TE: | AP | RLD: | No | ||||
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